Integral Cognitive Remediation for Depression

NCT07014683 | Completed DMC

• 1 other identifier: IIBSP-RID-2021-07
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if INCREM intervention can improve psychosocial functioning in patients with remitted major depressive disorder. The main question it aims to answer are: Does INCREM improve psychosocial functioning compared to psychoeducation? Does the benefits of INCREM remain after six months of the intervention compared to psychoeducation? Researchers will compare two arms: INCREM; psychoeducation to see if psychosocial functioning improves. Participants will be allocated to:

• INCREM
• Psychoeducation
• TAU.

Conditions

Major Depressive Disorder (MDD)

Keywords

cognitive symptoms; cognitive remediation; rehabilitation; functional recovery; major depressive disorder

Outcome Measures

Primary Outcomes (1)

• Functioning Assessment Short Test (FAST)

  The FAST is a valid, widely used instrument to test psychosocial functioning. The main outcome measure will be the percentage of change in FAST scores between T0 and T1 and T2.

  From enrollment to the end of treatment (12 weeks) and to the end of follow-up (6 months)

Secondary Outcomes (3)

• Hamilton Depression Rating Scale-17 items (HDRS_17)

  From enrollment to the end of treatment (12 weeks) and to the end of follow-up (6 months)

• Screening for Cognitive Impairment in Psychiatry (SCIP)

  From enrollment to the end of the intervention (12 weeks) and to the end of the follow-up (6 months)

• Perceived Deficits Questionnaire for Depression (PDQ-R)

  From enrollment to the end of the intervention (12 weeks) and to the end of follow-up (6 months)

Study Arms (2)

INCREM

EXPERIMENTAL

12-session integral cognitive remediation program specifically designed for depression.

Behavioral: INCREM

Psychoeducation

ACTIVE COMPARATOR

12-session psychoeducation program for depression

Behavioral: Psychoeducation

Interventions

INCREM BEHAVIORAL

This is a specifically designed program to improve psychosocial functioning which targets cognitive symptoms.

Also known as: cognitive remediation

INCREM

Psychoeducation BEHAVIORAL

This is a 12-session psychoeducation program designed as an active comparator for the current trial

Psychoeducation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients aged 18-60 y.o. and beyond with a remitted or active episode of major depression (DSM-5 criteria; maximum score of 18-20 on the HDRS-17) showing cognitive symptoms (scores below 80 on the SCIP) with functional difficulties (scores above 12 on the FAST).

You may not qualify if:

• IQ below 85;
• any unstable or inadequately-treated medical condition that may affect neuropsychological performance;
• being under drug treatment in the last 4 weeks with glucocorticoids, probiotics, non-steroidal anti-inflammatory drugs, bile acid sequestrants, immunosuppressive drugs, anti-histamines, mast cell stabilizers, and antioxidant supplements;
• use of systemic antibiotics the last 2 months;
• presence of any comorbid psychiatric condition, other than personality disorders or nicotine use disorders, in the last three months;
• accomplish criteria for severe treatment resistant depression;
• patients who had received electroconvulsive therapy in the previous year;
• patients receiving any other structured psychological intervention in the 3 months prior to the study;
• not having the necessary electronic means (computer or tablet) or internet connection to be able to participate.

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead

Study Sites (1)

Institut de Recerca Sant Pau- Mental Health Group

Barcelona, Catalonia, 08041, Spain

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Neurobehavioral Manifestations

Interventions

Cognitive Remediation

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Maria J Portella, Dr

  Fundació Institut de Recerca Hospital de la Santa Creu i Sant Pau

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2025
• First Posted: June 11, 2025
• Study Start: September 19, 2021
• Primary Completion: August 13, 2023
• Study Completion: August 13, 2023
• Last Updated: June 11, 2025

Record last verified: 2024-09

Locations

ES (1)